What is it about?
Artificial Intelligence is expected to transform some aspects of health and care delivery. Devising regulation that ensures the safety and effectiveness of medical systems incorporating AI poses significant challenges. This paper explores some of these challenges and sets efforts in the UK into the broader US and EU context.
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Why is it important?
The extent to which a principled overarching approach to the regulation of AI as a technology is challenged by considering particular application contexts (in this case health and care). This article explores the UK approach that is driven from risks in specific application domains while being guided by overarching principles. This illuminates some of the tension between a principled approach and more application-specific approaches.
Perspectives
This paper is a good opportunity to present some of our insights into the relationships between regulators, vendors, academics and users arising form a series of workshops. It was particularly interesting to work with legal, regulation science, and innovation studies scholars in the development of the paper.
Stuart Anderson
University of Edinburgh
Read the Original
This page is a summary of: Regulating AI/ML-enabled Medical Devices in the UK, July 2023, ACM (Association for Computing Machinery),
DOI: 10.1145/3597512.3599704.
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